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Requirements for a facility that is only using cGMPs

animal food cGMP food for animals FSMA 507 requirements no preventative control

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#1 Joe Hansen

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Posted 10 October 2017 - 04:40 PM

We contract growers to produce safflower which is then cleaned using a sizing machine and shipped for bird food in totes, bags, and bulk trucks. so far we have determined that preventative controls are not needed and plan to proceed using only cGMP, which is a decision that needs to be documented.

 

the question is: other than our hazard analysis and documentation of our decision not to use PCs what records are we required to keep if we do not plan on having any preventative controls?

 

At a secondary plant we follow Primus for human food and it would be relatively easy to convert any needed documents/policy to meet the animal feed requirements, but I'm looking for a baseline to start from. I've been told from other sources that we will not need a recall, or a supplier approval program. 


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#2 Joe Hansen

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Posted 11 October 2017 - 10:14 PM

I've got some information from the AFIA. If anyone has more information that would be helpful.

There are only two things that are a requirement: one is a hazard analysis that shows preventative controls are not necessary, and two is training records for "animal food hygiene" and "animal food safety." Also you need to designate a PCI who has received certification (the certification for 21cfs117 or human food does not cover this requirement). In the FDA's "Guidance for Industry #235" its says that the training only needs to be an initial training when an employee is hired and then retraining of "some form" they do not specify how frequently and have provided vary little information on what needs to be included in the training.

Any other records that you keep are not a "requirement" but may be necessary to prove that any cgmps and prerequisites that you listed on the hazard analysis are controlling any possible hazards. The Guidance for Industry document under VI lists several things that are expected, but how to document cgmps and prerequisites is left up to you.

long story short they are not "requiring" a lot in terms of record keeping, but you may have to do it anyway as evidence for your hazard analysis.


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